Is blockchain technology the solution to healthcare’s data woes?

In healthcare, blockchain is widely regarded as technology that
will protect data from costly and credibility-damaging cyberhacking. But there’s a risk; does it
align with regulatory bodies’ criteria?

Many experts believe blockchain technology will drive innovation
in health information and that it has the potential to solve critical
healthcare issues, including interoperability, security, records management and
data exchange. As with any new technology in a heavily regulated industry,
widespread adoption of blockchain technology in healthcare is highly dependent
on striking the right balance between innovation and regulation. Finding that
balance requires an understanding of both the technology and the regulatory boundaries.

The fundamentals of blockchain technology

At a fundamental level, blockchain technology is distributed
peer-to-peer ledger technology built around four key concepts: decentralised
digital trust, consensus protocol, immutability and security. Generally, blockchain
technology structures each transaction into chronologically recorded blocks of
data that are encrypted on a distributed (public, semi-private or private)
database (Linn and Koo 2016). Each hash in a blockchain database uses the new
data to be recorded and old data from a previous block to create a unique and
immutable digital signature for each new block of data (Linn and Koo 2016).

To verify that each subsequent block in a chain matches up with
all previous blocks (and is otherwise a valid transaction), blockchain
technology uses a form of consensus protocol to confirm transactions before they
are written to the database (Linn and Koo 2016). Each member (or node) in a
distributed blockchain network stores an identical copy of the entire database
and participates in the collective verification process in real time by
simultaneously running algorithms to confirm transactions (Economist 2016). Because
each new block’s hash is based on the hash of a previous block, any change to a
past transaction is immediately apparent to everyone in the chain when the hash
of a new block no longer matches up with the chain of blocks before it. At a
basic level, this network consensus and transparency increases security and
immutability of transactions that are written to the database and may replace a
trusted intermediary (Linn and Koo 2016).

What are the challenges of implementing blockchain technology in
healthcare?

One of healthcare’s greatest challenges is interoperability and
managing patient data across the continuum of care. Blockchain technology has
the potential to solve this challenge, but experts still express some technological
and regulatory concerns. Two challenges are scalability and privacy (IB M
Global Business Services Public Sector Team 2016).

Blockchain technology is ideal for smaller data units, but the
size of medical records would quickly make scalability problematic if applied
to a traditional blockchain structure (Linn and Koo 2016). Complete medical records
of each patient in a blockchain database would need to be stored at each
location participating in the network, and the data-storage and bandwidth
requirements needed to operate such a system would be prohibitively large (Linn
and Koo 2016). Instead, a blockchain technology-based medical system would
likely need to function as a control for accessing the data, noting where and
when changes to medical records occur, rather than containing the entire
dataset (Linn and Koo 2016). Blockchain databases can be designed so that large
files, like x-rays, are “off the chain,” but the links to the files are stored
“on chain” (Behlendorf 2017). Blockchain technology may be useful to generate
an audit trail for particularly sensitive healthcare transactions, such as the
prescribing of opioids. Given that medical information is worth 10 to 20 times
more than credit card data on the dark web (Humer and Finkle 2014), privacy
issues are also a concern for blockchain technology in healthcare (Cuomo 2016).
Jerry Cuomo, IBM’s Vice President of Blockchain Technologies, said “within
healthcare, more extensive privacy protections are needed . . . One goal is to
ensure that institutions and individuals can only access information they’re
supposed to see. A key element is ‘entitled access,’ which is achieved by using
modern cryptography so access to private data requires presentation of
encryption keys/certificates held by authorised participants” (Cuomo 2016). Various
solutions to the privacy issues posed by blockchain technology are available,
however. For example, a patient’s medical data must be encrypted, and
permission to read or write that data could be based on an encryption key only
known to the patient or his or her healthcare provider (Linn and Koo 2016). Another
possible solution is a fully private blockchain database, where permission to
read or write to the database is controlled by one organisation (eg a
regulatory body) (Buterin 2017).

While there are workable solutions to the technological challenges
of blockchain implementation in healthcare, finding solutions to the regulatory
challenges will require a greater collaborative effort by the healthcare industry
and will likely require action by healthcare regulators. For example,
traditional blockchain implementation may not be HIPAA compliant without additional
measures (LaFever 2016). Blockchain technology relies on mathematically derived
pseudonyms to verify the data on a distributed ledger (LaFever 2016). HIPAA
privacy rules may forbid this practice because the pseudonyms pose a risk of
potential re-identification of de-identified protected health information (PHI
) (LaFever 2016). If PHI is contained in and passed in a blockchain database,
would hundreds of business associate agreements be required to exchange
healthcare data under HIPAA?

Blockchain implementation also raises other regulatory issues,
including lack of an existing legal framework for regulating blockchain
technology (Tena 2017), lack of an established legal authority or data
governance that makes the rules and imposes sanctions, and finding ways to
incentivise the sharing of patient data and reform efforts. Despite these
regulatory challenges, there is evidence that regulators are taking notice, and
change may be on the horizon.

For example, federal agencies, such as the Departments of Homeland
Security, Justice and Treasury have been using blockchain services and
contractors since 2015 and are now devoting increased resources towards
blockchain innovation. Further, in 2016, the National Institutes of Health held
a competition seeking white paper submissions on blockchain technology and its
possible uses in healthcare (Linn and Koo 2016), and the FDA has partnered with
IBM in the hope of developing “a secure, efficient, and scalable exchange of
health data using blockchain technology” (IBM 2017).

The healthcare industry already has several blockchain initiatives
under way, including a permissions management project for data from clinical
trial patients, a patient-centric electronic health record on a permissionless
blockchain database, a health identity blockchain database established by the
Estonian government, and a blockchain-based healthcare claims management system
(Behlendorf 2017).

Understanding risks

Adoption of blockchain technology in healthcare will require small
test projects in exchanging and tracking data (Behlendorf 2017). Given the
success of blockchain implementation in other regulated industries, such as the
financial services industry, it makes sense to explore the opportunities for
blockchain technology in healthcare, while also understanding the potential risks.

Sharon Klein and Joe Guagliardo are vice chairs of Pepper
Hamilton’s Technology Group, a multipractice team that advises companies where
technology is the business as well as companies where technology is critical to
supporting the core business. Ms. Klein is also a member of the firm’s Health Sciences
Department, a team of 110 attorneys who collaborate across disciplines to solve
complex legal c hallenges confronting clients t hroughout the health sciences
spectrum. Research assistance for this article was provided by summer associate
John Melde.

References:

Behlendorf B (2017) The potential for blockchain technology in health IT. [Accessed: 23 August 2017] Available from himss.org/news/ potential-blockchain-technology-hit

Buterin V (2015) On public and private blockchains. Ethereum blog, 7 Aug. [Accessed: 23 August 2017] Available from blog.ethereum.org/2015/08/07/ on-public-and-private-blockchains

Cuomo G (2016) How to capitalize on blockchain. Testimony, United States House of Representatives Energy and Commerce Subcommittee on Commerce, Manufacturing & Trade, 16 March. [Accessed 23 August 2017] Available from: http://docs.house.gov/meetings/IF/IF17/20160316/104677/HHRG-114-IF17-Wstate-CuomoG-20160316.pdf

Economist (2015) The trust machine. The Economist, 31 Oct.[Accessed: 23 August 2017] Available from

Humer C, Finkle J (2014) Your medical record is worth more to hackers than your credit card. [Accessed: 23 August 2017] Available from reuters.com/article/us-cybersecurity-hospitals-idUSKCN-0HJ21I20140924

IBM (2017) IBM Watson Health announces collaboration to study the use of blockchain technology for secure exchange of healthcare data IBM, 11 Jan..[Accessed: 23 August 2017] Available from www-03.ibm.com/press/us/en/pressrelease/51394.wss

IBM Global Business Services Public Sector Team (2016) Blockchain: the chain of trust and its potential

to transform healthcare – our point of view. [Accessed: 23 August 2017] Available from healthit.gov/sites/default/files/8-31-blockchain-ibm_ideationchallenge_aug8.pdf

Linn LA, Koo MB (2016) Blockchain for health data and its potential use in health IT and health care related research. [Accessed: 23 August 2017] Available from healthit.gov/sites/default/files/11-74-ablockchainforhealthcare.pdf

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